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NCT03219164 · ClinicalTrials.gov registry record · Phase 3
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT03219164: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT03219164 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219164, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
Interventions
- DRUG Placebo
- DRUG AZLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2021-09-23 |
| Phase | Phase 3 |
Why NCT03219164 stopped before completion
NCT03219164 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03219164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03219164 about?
NCT03219164 is a clinical study titled "Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria". The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
What is the current status of trial NCT03219164?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2017-11-28. Estimated completion is 2021-09-23.
What interventions are being tested in trial NCT03219164?
The interventions under investigation include: Placebo (DRUG), AZLI (DRUG).
Who is sponsoring clinical trial NCT03219164?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03219164's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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